Summary:
Summary Statement of Deficiencies D0000 An onsite validation survey conducted on February 11, 2026, at Darrin's Place found the laboratory to be not in compliance with the CLIA regulations found at 42 CFR, Part 493 Laboratory Requirements, with standard deficiencies cited. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on direct observation, review of the Thermo Scientifc packet insert for the DRI Hydrocodone Assay Calibrator and Controls, calibration result, and interview with the technical consultant, the laboratory failed to ensure calibration reagents were not used beyond its expiration date for hydrocodone testing for 4 of 14 days reviewed in January and February 2026. Findings included: 1. During a tour of the laboratory on 02/11/2026 at 11:23 am, an opened bottle of DRI Hydrocodone Calibrator, lot number: 75452019 unopened expiration date: 2026 -10, with an open date of 12/01 /2025 and new written expiration date of 1/29/2026 was found in use in the reagent refrigerator. 2. Review of the Thermo Scientifc packet insert for the DRI Hydrocodone Assay Calibrator and Controls stated, "Once opened the calibrators and controls are stable for 60 days when stored at 2-8C (Celsius)" 3. Review of calibration results revealed calibration with the expired Hydrocodone Calibrator was used 02/02 /2026, 02/04/2026, 02/10/2026, and 02/11/2026. 4. During an interview on 02/11 /2026 at 11:56 am with the technical consultant, they stated that patient testing is done every day the laboratory is opened and confirmed the above findings. 5. The laboratory reports performing 70,000 toxicology tests annually. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --